CN114040784A

CN114040784A - Sterilization channel for medicine containers

Info

Publication number: CN114040784A
Application number: CN202080048181.9A
Authority: CN
Inventors: 朱塞佩·蒙蒂
Original assignee: Marchesini Group SpA
Current assignee: Marchesini Group SpA
Priority date: 2019-06-10
Filing date: 2020-06-09
Publication date: 2022-02-11
Anticipated expiration: 2040-06-09
Also published as: KR20220018039A; IT201900008445A1; WO2020250127A1; EP3980082B1; CN114040784B; EP3980082A1; US20220226515A1

Abstract

The sterilization tunnel (T) of the drug container comprises: an inlet opening (I) for the inlet of a container (C) to be extinguished; an outlet opening (O) for the outlet of the sterilization container (C); at least one sterilization chamber (S) for sterilizing the containers at an elevated temperature, and a cooling chamber (R) for cooling the sterilized containers, connected to the sterilization chamber (S) and communicating with the outlet opening (O). There is also conveyor means (1) for transporting the containers (C) through the sterilization chamber (S) and the cooling chamber (R) to the vicinity of the outlet opening (O), the continuous conveying plane (2) of the conveyor means (1) being positionable in a first alignment configuration (C1) with respect to the conveyor means (1) so as to convey the containers outside the tunnel (T) through the outlet opening (O) and the flap (3) for opening/closing the outlet opening. The conveying plane (2) is movable and positionable with respect to the conveyor device (1) in the second misaligned configuration (C2), in which the conveying plane (2) is arranged inside the cooling chamber (R) and the baffle (3) is lowerable to abut a sealing element (4) when the conveying plane (2) is inside the cooling chamber.

Description

Sterilization channel for medicine containers

Technical Field

The present invention relates to the technical field of filling containers (e.g. bottles, vials, etc.) with pharmaceutical products such as tablets, capsules or liquid compounds.

In particular, the present invention relates to a sterilization tunnel for drug containers through which drug containers to be filled are transported for sterilization.

Background

It is known that before inserting the pharmaceutical product inside the relative container, the latter must be suitably sterilized in order to eliminate the presence of any contaminating agents or residues.

In this respect, the containers to be sterilized are transported inside a sterilization tunnel, which is usually located upstream of the filling machine or upstream of an accumulation station, for example constituted by a turntable, in which the containers are accumulated before being led inside the filling machine.

The prior art sterilization tunnel comprises a closed environment with an inlet opening for the containers and an outlet opening for the containers, and conveyor means apt to receive the containers through the inlet opening and transport them to the outlet opening.

Inside the tunnel, between the inlet opening and the outlet opening, there is at least one sterilization chamber through which the containers are transported by the conveyor means.

For example, within a channel, there may be provided in sequence: the preheating chamber is easy to preheat the container; the sterilization chamber has higher internal temperature and is suitable for effectively sterilizing the container; a cooling chamber, the interior of which is impinged by a flow of filtered air to reduce its temperature, and then transported out of the channel through the outlet.

A conveyor device, such as an endless closed belt or mat, extends almost to the vicinity of the exit opening, with a winding end located in the vicinity of the exit opening.

The transport plane of the containers, which is located downstream and continuous from the conveyor device, receives the sterilized containers from the conveyor device and enables them to pass through the outlet opening outside the tunnel.

In this regard, a pusher member may be used to push the container to slide on the conveying plane and through the outlet opening.

At the outlet opening, the passage is equipped with a closing shutter movable between a raised position for opening the outlet opening and allowing the passage of the containers, and a lowered position for closing the outlet opening, the lowered position being adjacent to the conveying plane.

Once the sterilization cycle of a series of containers is completed and then filled with the relative pharmaceutical product, it is necessary to sterilize the cooling chamber before continuing with the subsequent sterilization cycle of the second series of containers, in order to eliminate the presence of any contaminating substances/agents that may be deposited inside the cooling chamber at the same time, for example during the time the shutter remains in the raised position to allow the passage of the containers.

In this respect, the baffle is positioned in a lowered position, close to the conveying plane, and the cooling chamber is subjected to a flow of filtered hot air to reach a high temperature suitable for sterilization.

However, the conveying flat portion covered with the baffle is not subjected to the impact of the hot air flow, and therefore, sufficient sterilization cannot be performed.

Another known type of sterilization tunnel is described in document WO 2017/158118.

This document describes a packaging plant comprising a combination of a sterilization tunnel of the above-mentioned type and a filling machine arranged in succession on the sterilization tunnel and having a conveyor for receiving outlet containers from the tunnel outlet, adjacent to the conveying plane of the sterilization tunnel at the baffle.

In this document, the transfer plane is movable between a first position, located at the outlet opening, and a second position, located between the sterilization tunnel and the conveyor of the filling machine, the second position being located outside the sterilization tunnel, beyond the outlet opening and inside the filling machine.

In this way, at the end of a production cycle, and before carrying out the sterilization and filling of other containers of the next production cycle, the conveying plane can be taken out of the channel through the outlet opening and placed in the filling machine.

The baffle can then be lowered to close the outlet of the channel and the cooling chamber can be subjected to a flow of filtered hot air in order to sterilize it.

At the same time, the sterilization of the relevant components must be carried out inside the filling machine, and therefore also the transport plane located therein.

This movement pattern of the transfer plane present in the sterilization tunnel downstream and at the outlet of the conveyor device is only useful in the case where the sterilization tunnel is used in a dedicated combination with a filling machine.

In fact, such a sterilization tunnel, in which the transfer plane can be moved outside the tunnel, cannot be used in all cases where it is necessary to use it in conjunction with a storage and accumulation station (for example a carousel) of the containers to be sterilized, from which the containers are then transferred to the filling machine.

By keeping the conveyor plane aligned with the conveyor device and moving the baffles to the lowered position of the conveyor plane support, and performing the sterilization operation of the cooling chamber, the problem of the previously issued signal will remain unchanged, that is to say, the portion of the conveyor plane covered by the baffles will not undergo any sterilization.

Furthermore, by moving the transport plane outside the tunnel and then lowering the shutter to close the outlet opening, to perform the sterilization operation of the cooling chamber, the transport plane, by remaining outside, will not be able to perform any sterilization operation, and therefore, once returned inside the tunnel and aligned with the conveyor device, may cause contamination.

Disclosure of Invention

It is therefore an object of the present invention to provide a new drug container sterilization tunnel that eliminates the disadvantages previously shown in prior art sterilization tunnels.

In particular, the object of the present invention is to provide a new medicine container sterilization tunnel which enables to efficiently perform the sterilization operations of the cooling chamber and all the related components, in particular a transport plane located downstream of the conveyor device and at the outlet opening, which transport plane can be used in combination with the filling machine, and in all these cases the sterilized containers must first be accumulated in an accumulation station before being introduced into the filling machine.

The above object is achieved by a sterile channel of a medicament container according to the claims.

Drawings

Features of preferred, but not exclusive, embodiments of the sterile tunnel for a pharmaceutical container according to the invention are described below with reference to the accompanying drawings, in which:

FIG. 1 is a side view in vertical section of the sterilization tunnel according to the invention;

figures 2A to 2F show, on a larger scale, a detail indicated by the letter K in figure 1, in which some important components of the sterilization tunnel are represented in various possible operating configurations;

figure 3 is a partial front view of the outside of the sterilization tunnel section, the container outlet being located outside said section;

figure 4 is a partial schematic view of the internal vertical section of the sterilization channel portion (in which the container outlet is located).

Detailed Description

Referring to the attached tables of the drawings, reference letter (T) denotes a sterilization passage of the medicine container of the present invention.

Implementations of the sterilization tunnel (T) include (e.g., with reference to fig. 1):

an inlet opening (I) for the inlet of a container (C) to be sterilized,

an outlet opening (O) for the outlet of the sterilization container (C);

at least one sterilization chamber (S) for sterilizing the containers at an elevated temperature, and a cooling chamber (R) for cooling the sterilized containers, connected to the sterilization chamber (S) and communicating with the outlet opening (O).

Conveyor means (1) for receiving the containers (C) from the inlet opening (I) and transporting the containers (C) through the sterilization chamber (S) and the cooling chamber (R) to the vicinity of the outlet opening (O).

A ventilation device (SM) (not described in detail as being of known type and not object of the present invention) is located in the sterilization chamber for directing a filtered air flow to the containers transported by conveyor means and heating means (not shown), heating the air flow to raise the temperature inside the sterilization chamber to a level sufficient to sterilize the containers.

Ventilation means (SM) are also present inside the cooling chamber (R) (also not described in detail as a known type, nor object of the present invention) for directing the air flow (at ambient temperature or at a lower temperature) to the containers transported by the conveyor means, and having left the sterilization chamber, reducing the temperature thereof.

The tunnel (T) also comprises a conveying plane (2), said conveying plane (2) being adjacent to the conveyor device (1) and being mounted with respect to the conveyor device (1) so as to be arrangeable in a first alignment configuration (C1) in which it is aligned with the conveyor device (1) and arranged at the outlet (O) so as to receive the sterile containers (C) from the conveyor device (1) and enable them to be conveyed from outside the tunnel (T) through the outlet (O).

The tunnel (T) further comprises a shutter (3), the shutter (3) being arranged and movable with respect to the outlet opening (O) and to the conveying plane (2) so as to be positionable in a raised Position (PS) to keep the outlet opening (O) open and to enable the exit of the sterilization containers (C), and in a first lowered position (PA1), abutting against the conveying plane (2) to close the outlet opening (O).

For example, before the start of the sterilization cycle, the shutter (3) is in a first lowered position (PA1) against the conveyor plane (2) to close the outlet opening (O) while waiting for the arrival of the containers transported by the conveyor device (1) (see, for example, fig. 1 and 2A), and then, upon the arrival of the sterilized and cooled containers, the containers are lifted to a raised Position (PS) (see fig. 2B) to open the outlet (O) and enable the containers to be conveyed by the conveyor device above the external conveyor plane (2) of the tunnel.

For conveying the containers along the conveying plane through the outlet opening, suitable pusher means (not shown in the figures of known type and not forming part of the object of the present invention) can be used, for example.

The special characteristics of the sterilization tunnel (T) of the present invention include its configuration and realisation, i.e. the conveying plane (2) is mounted with respect to the conveyor device (1) so as to be movable and positionable with respect to the conveyor device (1) in a second misaligned configuration (C2), in which the conveying plane (2) is misaligned with respect to the conveyor device (1) and arranged inside the cooling chamber (R) of the tunnel (T) (see in particular fig. 2C and 2D).

Furthermore, another particular aspect is that, when the transport plane (2) is moved and positioned in the second misaligned configuration (C2) and arranged inside the cooling chamber (R), the shutter (3) is movable so as to be positioned in a second lowered position (PA2) (fig. 2D), at a lower height than the first lowered position (PA1), in which the shutter (3) is positioned against the sealing element (4), to achieve a sealed closing of the cooling chamber (R) with respect to the external environment.

In this way, thanks to these particular characteristics, the transport plane (2) can be carried inside the cooling chamber (R) and the latter can be sealed from the external environment.

Thus, the sterilization operation of the cooling chamber and of all the transfer planes can be carried out effectively between the sterilization cycle of the containers and the next cycle.

In this respect, in the cooling chamber (R) there are suitable heating means (not shown), such as electric resistances, for heating the filtered air flow directed to the conveyor means (1) through the ventilation means (RM).

In particular, the conveying plane (2) is mounted with respect to the conveyor device (1) in such a way as to be movable with respect to the conveyor device (1) so as to be positionable in a second misaligned configuration (C2) so that the conveying plane (2) is arranged above the terminal portion of the conveying plane (1), below the flow of hot air directed by the ventilation means (RM), towards the conveyor device (1), which configuration is inclined with respect to the vertical direction so that the flow of hot air coming from the ventilation means (RM) can strike the entire surface of the conveying plane (see in particular fig. 2D).

Thus, at the end of the sterilization process of the cooling chamber (R), the entire transfer plane (2) will also be completely sterilized.

The shutter (3) can then be raised, the conveying plane (2) returned to the first alignment configuration (C1) and to the conveyor device (1), the shutter (3) being lowered to the first lowered position (PA1) against the conveying plane (2) to wait for the start of a subsequent sterilization cycle of another group of containers.

Thanks to the above characteristics, the sterilization tunnel (T) of the invention can be used with filling machines and accumulation stations of containers, since it is possible to guarantee an optimal sterilization of the transfer plane, since it can be brought inside the cooling chamber of the tunnel, in order to perform a proper and complete sterilization during the sterilization of the cooling chamber.

Further and other features of the sterilization channel of the present invention are described below.

It comprises a lateral boundary (11) for guiding containers arranged at the side of the conveyor device (1), wherein the conveying plane (2) is hinged to the lateral boundary (11) at a hinge point (a) and is movable in rotation about the hinge point (a) with respect to the lateral boundary (11) so as to be movable (C1) from a first aligned configuration with a second misaligned configuration (C2) in which the conveyor device (1) enters the interior of the cooling chamber (R) of the tunnel (T) from the conveyor device (1), and vice versa, from the second configuration (C2) into the first configuration (C1).

In particular, according to a preferred but not exclusive embodiment shown in the figures, the conveying plane (2) is hinged to the transversal border (11) by means of a support arm (21), the support arm (21) being fixed on one side, bilaterally to the conveying plane (2), and on the other side, hinged to the transversal border (11) at a hinge point (a).

For rotating the transfer plane (2) around the hinge point (a), suitable actuator means can be used, for example at least one shaft mounted at the hinge point and constrained to the support arm (21), rotatably activated by means of an associated motor or other equivalent activation system.

The conveying plane (2) may comprise side walls (22) for receiving and guiding the containers (C) as they pass through the outlet opening (O), while the shutter (3) comprises a lower portion (30) shaped so as to have a projecting central portion (31) sized to be inserted between the side walls (22) and to abut against the conveying plane (2) when the shutter (3) is in the first lowered position (PA1) (see, for example, fig. 3 and 4).

Another particular aspect relates to the fact that: when the transport plane (2) is to be moved and positioned from the first alignment configuration (C1) to the second alignment configuration (C2), the shutter (3), and vice versa, from the second alignment configuration (C2) to the first alignment configuration (C1), can be raised to a height such as to leave enough operating space to move and move the transport plane (2) (see fig. 2C and 2E). The sterilization tunnel (T) may advantageously comprise a bearing element (5) located between the conveyor device (1) and the outlet opening (O), in a bearing and supporting position of the conveying plane (2) when the conveying plane (2) is positioned in the first alignment configuration (C1) of the conveyor device (1), to keep the conveying plane (2) aligned with the conveyor device (1) of the outlet opening (O) (see, for example, fig. 2A, 2B and 2F).

The channel (T) further comprises a gas-filled seal (G) arranged around the outlet opening (O) inside the channel (T).

When the shutter (3) has to move between a raised Position (PS) and a first lowered position (PA1) (see, for example, fig. 2A, 2B, 2C, 2E and 2F) with respect to the outlet opening (O), the inflatable seal (G) remains uninflated, therefore deflated and inflated to abut against the shutter (3), when the shutter (3) is in the second lowered position (PA2) to abut against the sealing element (4) (see fig. 2D) and to ensure the sealed closing of the cooling chamber (R) with respect to the external environment.

From the above description, the sterilization tunnel of the invention effectively eliminates the drawbacks of sterilization with respect to the conveying plane present in the sterilization tunnels of the prior art, enabling the sterilization tunnel of the invention to be used directly in connection with filling machines and enabling the use of the accumulation station of containers in connection with filling machines.

Claims

1. A sterilization tunnel (T) for pharmaceutical containers, comprising:

an inlet opening (I) for the inlet of a container (C) to be sterilized,

an outlet opening (O) for the outlet of the sterilization container (C);

at least one sterilization chamber (S) for sterilizing said containers at an elevated temperature, and a cooling chamber (R) for cooling said sterilized containers, connected to said sterilization chamber (S) and communicating with said outlet opening (O);

-conveyor means (1) for receiving said containers (C) from said inlet opening (I) and for transporting said containers (C) through said sterilization chamber (S) and said cooling chamber (R) to the vicinity of said outlet opening (O);

-a transfer plane (2) located in an adjacent position to said conveyor device (1), wherein said transfer plane (2) is mounted with respect to said conveyor device (1) so as to be arrangeable in a first alignment configuration (C1), wherein said transfer plane (2) is aligned to said conveyor device (1) and arranged at said outlet opening (O) in order to receive said sterile container (C) from said conveyor device (1) and enable it to be transferred from outside said tunnel (T) through said outlet opening (O);

a shutter (3) arranged and movable with respect to said outlet opening (O) and to said conveying plane (2) so as to be positionable in a raised Position (PS) to keep said outlet opening (O) open and to enable the exit of said sterilization containers (C), and in a first lowered position (PA1) abutting said conveying plane (2) to close said outlet opening (O);

characterized in that the mounting of the conveying plane (2) with respect to the conveyor device (1) is such as to ensure that the conveying plane (2) is movable and positionable with respect to the conveyor device (1) in a second misaligned configuration (C2), in which the conveying plane (2) is misaligned with respect to the conveyor device (1) and arranged inside the cooling chamber (R) of the tunnel (T), in which the shutter (3) is movable to be positioned in a second lowered position (PA2) at a lower level than the first lowered position (PA1), in which the shutter (3) is positioned against a sealing element (4), when the conveying plane (2) is moved and positioned in the second misaligned configuration (C2) and arranged inside the cooling chamber (R).

2. Sterilization tunnel (T) according to claim 1, comprising a transversal boundary (11) for guiding the containers arranged at the side of the conveyor device (1), wherein the conveying plane (2) is hinged to the transversal boundary (11) at a hinge point (a) and is movable in rotation about the hinge point (a) with respect to the transversal boundary (11) so that it can be moved from the first aligned configuration (C1) with the conveyor device (1) to the second misaligned configuration (C2), from the conveyor device (1) to inside the cooling chamber (R) of the tunnel (T), and vice versa, from the second configuration (C2) to the first configuration (C1).

3. Sterilisation tunnel (T) according to claim 2, wherein the transfer plane (2) is hinged to the transversal border (11) by means of support arms (21), the support arms (21) being fixed on one side, both sides being fixed to the transfer plane (2), the other side being hinged to the transversal border (11) at the hinge point (a).

4. Sterilization tunnel (T) according to claim 3, wherein said conveying plane (2) comprises side walls (22) for receiving and guiding said containers (C) when they pass through said outlet opening (O), wherein said baffle (3) comprises a lower portion (30), said lower portion (30) having a protruding central portion (31) sized to be inserted between said side walls (22) and to abut said conveying plane (2) when said baffle (3) is in said first lowered position (PA 1).

5. Sterilization tunnel (T) according to any one of the preceding claims, wherein a shutter (3), and vice versa, moving from the second alignment configuration (C2) to the first alignment configuration (C1) is raisable to a height to free sufficient handling space to move and transfer the transport plane (2) when the transport plane (2) is to be moved and positioned from the first alignment configuration (C1) to the second alignment configuration (C2).

6. Sterilisation tunnel (T) according to any one of the preceding claims, comprising a bearing element (5) located between said conveyor device (1) and said outlet opening (O), the position of which constitutes a bearing and support (C1) of said transfer plane (2) to said conveyor device (1) when said transfer plane (2) is in said first alignment configuration, so as to keep said transfer plane (2) aligned with said conveyor device (1) of said outlet opening (O).

7. Sterilisation tunnel (T) according to any one of the preceding claims, comprising a gas-filled seal (G) arranged around the outlet opening (O) inside the tunnel (T), said gas-filled seal (G) remaining uninflated and therefore deflated, between the raised Position (PS) and the first lowered position (PA1), and being gas-filled and therefore inflatable, when the shutter (3) must be movable with respect to the outlet opening (O), so as to abut the shutter (3) when the shutter (3) is in the second lowered position (PA2) to abut the sealing element (4).